A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

This study has been completed.
Sponsor:
Information provided by:
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00574223
First received: December 14, 2007
Last updated: April 24, 2009
Last verified: April 2009
  Purpose

The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind placebo-controlled setting


Condition Intervention Phase
Perennial Allergic Rhinoconjunctivitis
House Dust Mite Allergy
Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, Immunogenicity and Clinical Efficacy of a Specific Immunotherapy Combining Allergen With CYT003-QbG10 (CYT005-AllQbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Due to House Dust Mite Allergy

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:
  • Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life [ Time Frame: about 1.5 hours on 4 occasions over 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of the study treatment by collection of adverse events [ Time Frame: about 30 min. at each visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
subcutaneous injections at 8 visits
Placebo Comparator: Arm 2 Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
subcutaneous injections at 8 visits

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate perennial allergic rhinoconjunctivits due to hypersensitization towards house dust mite allergens

Exclusion Criteria:

  • Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
  • Use of any concomitant medication that could affect the patient's study treatment response or assessment results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574223

Locations
Switzerland
Cytos Biotechnology (Sponsor's Headquarter)
Schlieren, Switzerland, CH-8952
Sponsors and Collaborators
Cytos Biotechnology AG
Investigators
Study Director: Philipp Mueller, MD Cytos Biotechnology
  More Information

No publications provided

Responsible Party: Philipp Mueller, MD, Head of Clinical Development, EVP, Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT00574223     History of Changes
Other Study ID Numbers: CYT005-AllQbG10 04
Study First Received: December 14, 2007
Last Updated: April 24, 2009
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 23, 2014